William J. Gradishar, MD

Molecular screening identified patients with specific mutations that could be matched to targeted agents currently being tested in clinical trials.

The concept of personalized or precision medicine has been an aspirational mantra for oncologists for many years. The notion that we could tailor therapy to the specific biology of each tumor held the promise of greater anti-tumor efficacy than the standard “one-size-fits-all” approach. With commercial enterprises available to analyze an individual tumor for specific mutations, the concept of precision medicine is closer to reality in oncology — or is it?

With the aim of providing targeted therapy matched to a tumor's genomic alterations, French investigators conducted a multicenter molecular screening trial in which 407 biopsy samples from 423 patients with metastatic disease were assessed using comparative genomic hybridization array (67% of patients) and DNA sequencing (70%). The primary objective was to include 30% of patients in clinical trials designed to test therapies targeted to specific mutations identified in the biopsy specimens.

The most frequent targetable genomic alterations were found in PIK3CA (25% of alterations), CCDN1 (19%) and FGFR1 (13%). Based on these findings, therapy could ultimately be personalized in a clinical trial in 55 patients (13%); among the 43 of these patients who received a targeted agent, 4 (9%) achieved an objective response, and another 9 (21%) achieved stable disease for >16 weeks.

CITATION(S):

André F et al. Comparative genomic hybridisation array and DNA sequencing to direct treatment of metastatic breast cancer: A multicentre, prospective trial (SAFIR01/UNICANCER). Lancet Oncol 2014 Feb 6; [e-pub ahead of print].